FDA approves Allergan’s “Gummy Bear” implants – Style 410

At long last: The FDA approved Allergan’s Style 410 silicone breast implants today. This is the long-awaited “Gummy Bear” implant, which is filled with thicker “form-stable” silicone. The implants have been in use in Canada and Europe for a number of years, and American plastic surgeons have been waiting…and waiting…and waiting for the FDA to make this announcement. So it’s big news.

These implants are very different from the silicone gel implants we use now. First of all, they are teardrop shaped, not round. They are textured, not smooth. They are dramatically firmer – some people might say “too firm” – and require a larger incision to put in. However, in case of a crack or break in the implant shell, the firm silicone gel does not leak out- it stays put.

They come in 12 different families of shapes – which might be a little overwhelming for patients who are trying to figure things out. We’re still learning how to accurately recommend the best shape for a given woman’s body type.

At the time of surgery, the surgeon must be extra-accurate about making the implant pocket just the right size. Too big, and the implant has a chance of rotation inside the breast. Since the implant is teardrop shaped, rotation of the implant would make the breast shape look weird, with the big part of the implant in the wrong part of the breast.

We’ll have to see whether these catch on with the American public for cosmetic purposes. In Canada, they represent only about 10-15% of the implant market. I think they will be really helpful for breast reconstruction, and for women that don’t want much roundness in the upper part of the breast contour.